Medical Device Testing Services

Noble Life Sciences offers a wide range of testing GLP services to ensure both the efficacy and safety of medical devices with significant expertise in orthopaedic, cardiovascular, trauma, and wound models. We provide surgical expertise and support utilizing state of the art equipment

SERVICE OPTIONS

GLP and non-GLP protocol development
Prototype evaluation
Multi-species in vivo testing
Novel preclinical model development
Complex surgical procedures
Regulatory support

OPERATIONS

FDA inspected GLP facility
Standard operating procedures (SOP’s) that cover all aspects of animal care, animal procedures, equipment operation and facility operation
Accredited by the Association for the Assessment and Accreditation of Laboratory Animal (AAALACi) since 1989
Operates in full accordance with the Animal Welfare Act and the PHS Policy on Humane Care and Use of Laboratory Animals and the NRC Guide for the Care and Use of Laboratory Animals

FACILITIES

24,000 square feet of animal housing, support, and laboratory space securely situated in a one hundred acre campus
8,000 sq. ft. of conventional and 14,000 sq. ft. of specific pathogen-free (SPF) housing and support space

STAFF

Surgeons, board-certified veterinarians, and AALAS-certified technicians with more than 15 years of medical device and GLP experience.
Research interventionalist to help with protocol development; catheter and device placement; and basic cardiology and electrophysiology
Quality assurance professionals over 25 years of experience

CAPABILITIES

Surgery

Two surgical suites with recovery room, intensive care area, and preparation area
Wide range of imaging, surgery and specialized equipment

Laboratory

Blood collection and processing
Necropsy, histology, pathology/ histopathology
Clinical pathology—clinical chemistry, hematology, coagulation factor and urinalysis

Imaging

Biophotonic imaging system for whole body, real-time in vivo imaging
C-arm imaging scanner intensifier with radiographic capabilities fo animal imaging
Radiography
Ultrasound

MODEL OPTIONS

Cardiovascular

Models of acute myocardial infarction (with or without reperfusion)
Heart valve studies
Peripheral arterial disease • Thrombosis models
Venous/arterial grafts
Cardiac assist devices
Microvascular surgery

Trauma

Critical care training for traumatic injuries
Hemostasis

Wound Healing

Full thickness defect
Skin graft
Burn models
Diabetic models

Orthopedics

Joint Models
Osteoarthritis
Arthroplasty (hip, knee) and other types of articular cartilage repair
Anterior cruciate ligament (ACL) repair/ meniscectomy
Artificial meniscus
Reconstruction/fixation of other ligaments and tendons
Artificial ligaments and tendons
Bone Defect Models
Osteotomy of femur, tibia and radius
Critical size defect models in the calvarium, tibia, fibula, femur,
radius and ulna
Spinal Fusion Models
PLIF
PLIBF